La Vergne, TN, United States
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls
15 recalls recorded since 2018, most recently on 12 September 2025. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)6
Terminated or completed9
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 12 September 2025
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0013-2026, D-0011-2026, D-0010-2026, D-0009-2026, D-0012-2026
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)003090471306
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132
Ongoing Class II Drugs
- Recall started
- 2 September 2025
- Reason
- Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Distribution
- USA Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0625-2025, D-0624-2025
- Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing
- Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, ND
Ongoing Class II Drugs
- Recall started
- 20 August 2025
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Distribution
- Product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0594-2025
- Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Ongoing Class II Drugs
- Recall started
- 14 April 2025
- Reason
- CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0366-2025
- ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Terminated Class III Drugs
- Recall started
- 4 March 2025
- Terminated
- 23 February 2026
- Reason
- Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0304-2025
- Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Ongoing Class II Drugs
- Recall started
- 30 January 2025
- Reason
- Failed Dissolution Specifications.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0221-2025
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ
Ongoing Class II Drugs
- Recall started
- 21 January 2025
- Reason
- Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
- Distribution
- Nationwide U.S. and Puerto rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0226-2025, D-0227-2025, D-0228-2025
- Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Maj
- Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major
Terminated Class II Drugs
- Recall started
- 13 January 2025
- Terminated
- 5 March 2026
- Reason
- CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0212-2025
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major
Terminated Class II Drugs
- Recall started
- 7 November 2024
- Terminated
- 5 March 2026
- Reason
- Failed Impurity/Degradation Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0050-2025, D-0049-2025
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
- Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Terminated Class III Drugs
- Recall started
- 5 November 2024
- Terminated
- 16 September 2025
- Reason
- Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0045-2025
- Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Terminated Class II Drugs
- Recall started
- 18 June 2024
- Terminated
- 22 December 2025
- Reason
- Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Distribution
- Nationwide. No foreign consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0584-2024
- Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park D
Terminated Class II Drugs
- Recall started
- 9 February 2024
- Terminated
- 22 December 2025
- Reason
- an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
- Distribution
- The product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0324-2024
- HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia M
Terminated Class I Drugs
- Recall started
- 31 October 2023
- Terminated
- 15 April 2025
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0107-2024, D-0108-2024
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
- Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
Terminated Class I Drugs
- Recall started
- 23 October 2023
- Terminated
- 10 July 2024
- Reason
- Failed Content Uniformity Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0153-2024
- Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Terminated Class I Drugs
- Recall started
- 31 May 2023
- Terminated
- 2 July 2024
- Reason
- Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0893-2023
- ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.